Medtronic Inc's CoreValve system obtains early FDA approval on clinical performance

Friday, 17 Jan 2014 10:42am EST 

Medtronic Inc:Says the U.S. Food and Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery.Says FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S.Says Pivotal Trial, which demonstrated that the CoreValve System is safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported.Says In the U.S. Pivotal Trial, the CoreValve System also achieved exceptional hemodynamics, or blood flow, post-implant with results similar to the gold standard, surgical valves. 

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